Microscopic Hematuria
Conditions
Keywords
Hematuria, Menopause, Urinalysis
Brief summary
The purpose of this study is to determine if vaginal estrogen use is associated with resolution of blood in the urine (microscopic hematuria) in postmenopausal women. The hypothesis is that postmenopausal women with blood in the urine (microscopic hematuria) will have higher rates of resolution of hematuria after treatment course with vaginal conjugated equine estrogen cream compared to placebo cream
Detailed description
This is a randomized controlled trial of vaginal estrogen cream for postmenopausal women with microscopic hematuria (AMH). Potential subjects will be screened with a dipstick urinalysis of a catheterized urine specimen, followed by microscopic urinalysis and urine culture if urine dipstick is positive for trace blood or greater. Women who are identified as having asymptomatic microscopic hematuria (\>3 red blood cells (RBC) per high powered field (hpf)) on a single urine microscopy specimen in the absence of urinary tract infection or other benign cause will be eligible for enrollment. Women meeting inclusion criteria will be randomized to either conjugated equine estrogen cream (Premarin, 0.625mg conjugated estrogens) or placebo cream for 8 weeks. Microscopic urinalysis of a catheterized urine specimen will be re-checked at 8 weeks to check for reduction, resolution or persistence of AMH. During the 8 weeks of vaginal estrogen or placebo, women will complete the recommended AMH workup as dictated by the American Urologic Association (AUA) guidelines (cystourethroscopy, serum blood urea nitrogen and creatinine levels, and computed tomography (CT) scan of the abdomen and pelvis with and without intravenous contrast).1 Validated questionnaires to assess vaginal atrophy and symptoms of urinary urgency and frequency will be completed at time of randomization and again at 8 weeks. Cost analysis of the standard AMH workup (cystourethroscopy and CT scan) versus empiric treatment with 8 weeks of vaginal estrogen cream will be calculated based on Medicare reimbursement, as well as market price for vaginal estrogen cream Additionally, patients will be asked to complete a questionnaire to assess the level of bother associated with completing the current AMH workup of CT scan and cystoscopy as compared to completing a treatment course of vaginal estrogen cream. Secondary analyses will determine whether there are additional benefits to a trial period of vaginal estrogen cream in postmenopausal women with AMH prior to reflexively screening for urinary tract abnormalities. We will compare the cost of a standard AMH workup to a treatment course of vaginal estrogen cream, to determine whether vaginal estrogen with potential resolution of AMH is associated with any savings prior to pursuing further workup. Additionally, questionnaires will ask study participants whether they would prefer to undergo the current AUA AMH workup or a treatment course of vaginal cream, in order to assess bother and anxiety associated with these interventions.
Interventions
DRUGPremarin vaginal estrogen cream
Inactive vaginal cream manufactured to mimic Premarin vaginal cream
Sponsors
Pfizer
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Post-menopausal women * Asymptomatic microscopic hematuria (three or more red blood cells per high powered field on a single urine microscopy) in the absence of urinary tract infection.
Exclusion criteria
* Known urologic disease * Presence of gross hematuria * Presence of indwelling urologic foreign body (foley catheter, ureteral stent) * Inability to obtain intravenous contrast CT scan (elevated creatinine, severe contrast allergy) * History of pelvic irradiation or malignancy * Not a candidate for vaginal estrogen * Allergy to vaginal estrogen * Current or prior diagnosis of breast or endometrial cancer * History of deep vein thrombosis/pulmonary embolus * Hypercoagulable state
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Resolution of Microscopic Hematuria | 8 weeks | Microscopic urinalysis will be performed after an 8 week trial of vaginal estrogen or placebo. Resolution of microscopic hematuria is defined according to AUA guidelines, \<3 red blood cells per high powered field. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Improvement in Symptoms of Urinary Frequency and Urgency | 8 weeks | To determine the effect of vaginal estrogen compared to placebo on symptoms of urinary frequency and urgency. Participants that experience at least one point reduction in OAB-q score will qualify as a participant with improvement in these symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Premarin Vaginal Cream Premarin vaginal cream to be applied intra-vaginally and to vulva as follows: 1 gram nightly for 2 weeks, followed by 0.5 gram twice weekly for 6 weeks.
Premarin vaginal estrogen cream | 15 |
| Placebo Vaginal Cream Placebo vaginal cream to be applied intra-vaginally and to vulva as follows: 1 gram nightly for 2 weeks, followed by 0.5 gram twice weekly for 6 weeks.
Placebo vaginal cream: Inactive vaginal cream manufactured to mimic Premarin vaginal cream | 14 |
| Total | 29 |
Baseline characteristics
| Characteristic | Premarin Vaginal Cream | Placebo Vaginal Cream | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 7 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 7 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 5 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 4 Participants | 6 Participants | 10 Participants |
| Sex: Female, Male Female | 15 Participants | 14 Participants | 29 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 |
Outcome results
Primary
Number of Participants With Resolution of Microscopic Hematuria
Microscopic urinalysis will be performed after an 8 week trial of vaginal estrogen or placebo. Resolution of microscopic hematuria is defined according to AUA guidelines, \<3 red blood cells per high powered field.
Time frame: 8 weeks
Population: There were 14 participants in Placebo arm, 10 completed study and 4 were lost to follow up. 6 in Placebo group had resolution of microhematuria.~There were 15 participants in Estrogen arm, 10 completed study and 5 were lost to follow up. 10 in Estrogen group had resolution of microhematuria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Premarin Vaginal Cream | Number of Participants With Resolution of Microscopic Hematuria | 10 participants |
| Placebo Vaginal Cream | Number of Participants With Resolution of Microscopic Hematuria | 6 participants |
Secondary
Number of Participants With Improvement in Symptoms of Urinary Frequency and Urgency
To determine the effect of vaginal estrogen compared to placebo on symptoms of urinary frequency and urgency. Participants that experience at least one point reduction in OAB-q score will qualify as a participant with improvement in these symptoms.
Time frame: 8 weeks
Population: OAB-q scores were collected at baseline and at follow-up. Subjects with at least one point reduction in OAB-q score were recorded to show improvement in OAB-q score. Seven participants in the test group showed a reduction of at least 1 point and seven participants in the control group showed a reduction of at least 1 point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Premarin Vaginal Cream | Number of Participants With Improvement in Symptoms of Urinary Frequency and Urgency | 7 Participants |
| Placebo Vaginal Cream | Number of Participants With Improvement in Symptoms of Urinary Frequency and Urgency | 7 Participants |